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Medical Writer Specialist
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CORE JOB TASK:
  • To provide relevant literature retrieval for compounds, the progress of clinical studies and other information
  • To attend data analysis and presentation meeting and work with statistician on analysis plan and analysis report, review dry-run results
  • To develop high quality clinical documents: Clinical Study Report, Risk Management Plan, CTD submission documents (summary of clinical efficacy and safety, and efficacy and safety updates)
  • To prepare abstracts, posters, slide presentations, and publications in collaboration with investigators, marketing, and clinical team members based on results from clinical trials
  • To report adverse drug events in accordance with national regulations and internal establishments, including the medicine both under clinical research and post marketing, write narratives for death, SAE and other events as required
  • To maintain up-to-date knowledge and competencies within relevant therapeutic and professional areas
REQUIREMENTS:
  • Master Degree or above in life science (clinical medicine is a plus)
  • Strong verbal and written English (equals to CEF B2,  BEC V, IELTS 6.5) /Japanese
  • Good understanding of statistics and excellent interpretation and presentation skills, ability to accurately and clearly present clinical data
  • Strong self-motivate, positive, energetic
  • Ability to work independently, be able to work under pressure
  • Doctor’s license and/or work experience in hospital or clinical development is a plus
Location:
Beijing, Shanghai
Medical Monitor Manager
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CORE JOB TASK:
  • Provide overall medical and safety oversight of clinical trials as assigned
  • Challenge appropriately the study extended synopsis based on feasibility pre-assessment, protocol complexity index and associated cost
  • Interact with inter-departmental and external consultants, investigators, and regulatory agencies as appropriate
  • Review/approve medical-related documents (e.g. specifications for centralized services, Protocol, ICF, CRF, CRF completion guidance, patient diary, etc.) as needed
  • Secure trial master file (medical related documents) readiness and availability, and mandatory trainings linked to the function
  • Conduct medical and safety monitoring, review clinical lab values, AEs, coding dictionaries, assist with data safety monitoring board activities
  • Provide medical answers to questions from Health Authorities, IRB/Ethics Committees, Investigators, experts, clinical study team
  • Participate and present in investigator meetings, contribute to steering committees, data monitoring committees meetings, adjudication committees and prepare related material (e.g. charter, presentations)
REQUIREMENTS:
  • Master Degree or above in clinical medicine, Ph.D. or M.D. is a plus
  • Around 4 years’ work experience and 2 years of medical monitoring
  • Fluent verbal and written English (equals to CEF C1, BEC H, IELTS 7.0) /Japanese
  • Ability to work independently and handle multiple tasks simultaneously under pressure
  • Good communication skills and good team player
  • Ability to coach other junior medical monitors
  • Global, cross-cultural perspective and customer orientation 
Location:
Beijing, Shanghai (Tianjin, Guangzhou, Wuhan, Chengdu can also be considered)
Medical Monitor Specialist
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CORE JOB TASK:
  • Work with Medical Writer to develop, review and finalize study protocols and reports, contribute to trial design, develop, review and revise IND/CTA documents, protocols, IB, CRF, ICF, IRB/EC documents, SAP, CSR and NDA documents
  • Responsible and accountable for overall supervision/execution of medical validation/review of study data, including writing or supervision of study related documents (e.g.: medical monitoring plan, guidelines, etc…)
  • Act as a key driver to assigned clinical projects, provide medical and scientific expertise to project teams, participate in project feasibility and risk assessment
  • Help medical manager to prepare materials for investigator meetings, participate and present in investigator meetings, contribute to steering committees, data monitoring committees meetings, adjudication committees and prepare related material (e.g. charter, presentations)
  • Conduct medical and safety monitoring, review clinical lab values, AEs/SAEs, coding dictionaries, assist with data safety monitoring board activities
  • Maintain medical expertise in therapeutic domain
REQUIREMENTS:
  • Master Degree or above in clinical medicine, Ph.D. or M.D. is a plus
  • Doctor’s license and at least 1 year work experience in a hospital, or at least 1 year work experience as a medical monitor
  • Strong verbal and written English (equals to CEF B2,  BEC V, IELTS 6.5) /Japanese
  • Good understanding of statistics and excellent interpretation and presentation skills, ability to accurately and clearly present clinical data
  • Strong self-motivate, positive, energetic
  • Ability to work independently, be able to work under pressure
Location:
Beijing, Shanghai (Tianjin, Guangzhou, Wuhan, Chengdu can also be considered)
Medical Translator
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CORE JOB TASK:
  • Perform translations for technical or regulatory documents in pharma and medical device
  • Perform proofreading for the primary translated technical or regulatory documents in pharma and medical device

Documents Involved

Pharma:

  • From English to Chinese: Clinical trial Protocol, Investigator’s Brochure (IB), Clinical Study Report (CSR), Informed Consent Form (ICF), Company Core Data Sheet (CCDS), Clinical Trial Agreement (CTA), Suspected Unexpected Serious Adverse Reaction (SUSAR), Periodical Safety Update Report (PSUR), etc.
  • From Chinese to English: Clinical literature, AE case report, etc.

Medical Device:

  • From English to Chinese: Clinical Evaluation Report (CER), Package Insert or Instructions for Use (IFU), Technical literature, etc.
  • Product Classifications: Orthopedic Product, Cardiovascular Product, Electro-engineering Product, Medical Consumables, Testing Instrument, etc.
  • From Chinese to English: Product Standard, Technical Specifications, Regulatory Policies/Guidelines, Test Report, etc.
REQUIREMENTS:
  • Majors in English or pharmaceutical/medical device; English: CET 6 or above
  • Maintains at least 2 years of job experience in translation or editing profession.
  • Excellent use of Chinese and English language to deliver high quality of technical or regulatory translations for end customer use;
  • Good understanding of medical content to meet requirements for qualified translations for both English and Chinese;
  • Good coordination/communication with relevant personnel on assignment;
  • Team oriented;
  • Be punctual.
Location:
Beijing
Pharmacovigilance Specialist
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CORE JOB TASK:
  • Receive, review and process safety operational data from various sources on time, within budget and quality standards.
  • Make sure safety reporting especially SAE reporting process within the required timeframe.
  • AE/SAE/ADR information collection, clarification, review and make sure the safety data release to sponsor (as appropriate) within the timeframe. 
  • Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
  • Build a positive, collaborative team environment with safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist operations with appropriate allocation of resource.
  • Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
  • Routinely communicate internally for AE/ drug safety inquiry and GCP issues.
  • For ongoing clinical projects, to ensure quality according to the requirement of ICH GCP and SOPs and relevant local regulation.
REQUIREMENTS:
  • Bachelor degree in Medicine, Pharmacy, Biology, or other relevant disciplines
  • Hands-on experience at least one year in Pharmacovigilance/Drug Safety required, experiences in clinical medicine, clinical research, clinical lab, data management, English translation, or other relevant areas preferred.
  • Self-motivated, excellent in communication, work planning and time management.
  • Good oral and written English skills.
  • Good sense and awareness of regulations and policies. 
  • Able to work under the pressure, strong sense of responsibility and accountability.
Location:
Beijing
(Senior) Regulatory Affairs Manager
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CORE JOB TASK:
  • To coordinate and manage the regulatory start-up activities and staff in a manner that ensures timeline and quality targets are met.
  • Maintain a clear overview of regulatory requirements. Monitor, identify and implement regulatory activities.
  • Communicate with regulatory agencies/institutes (e.g. CFDA) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing.
  • Maintain relationships with regulatory authorities.
  • Maintain up-to-date knowledge on regulatory requirements in their regions
  • Highlighting the training needs and developing the teams’ goals.
  • Development of senior members of the team and delegation of tasks to them.
  • Ensure all translating and compiling dossiers are correct and in compliance with Chinese regulation and effectively summarize professional report in verbal and written for drug registration.
  • Manage the custom release application of the import samples for regulatory use and solve the problems timely.
REQUIREMENTS:
  • Bachelor or above degree in pharmaceutical or chemical/biopharmaceutical sciences
  • With 6 or above years of pharmaceutical regulatory affairs or related experience in China. Import drug registration experience preferred.
  • Good command of project management, problem solving, planning and prioritizing.
  • Relevant depth of knowledge with respect to national/regional/global regulations as well as technical guidance.
  • Demonstrated experience interacting with CFDA successfully; familiarity with relevant CFDA officers.
  • Fluency in written and spoken English. 
  • Proficiency in Excel and other MS Office tools.
  • Well-organize with strong sense of responsibility. Work orderly and efficiently .
Location:
Beijing
Regulatory Affairs Supervisor, Medical Device
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CORE JOB TASK:
  • Prepare and submit registration application and dossier, follow up testing and evaluation procedure, obtain product license from CFDA independently.
  • Work closely to CFDA and testing center, establish and maintain good relationship.
  • Well coordinate with internal & external customers, have great communication skills – need to liaise with a lot of different parties both inside and outside the company (including oversea sponsor, medical department, testing center and evaluation center etc.).
  • Adapt to rapid changes in business environment, meet different requirements.
REQUIREMENTS:
  • Bachelor or above degree of medical, chemistry, pharmaceutical, biological, or relatives.
  • With 6 or above years of pharmaceutical regulatory affairs or related experience in China. Import drug registration experience preferred.
  • Excellent inter-personal, communication and presentation skill.
  • Fluency (oral and written) in both Chinese and English.
  • Be patient and earnest on product registration projects.
  • Good team player.
  • Independently handle project ability
  • With experience in handling imported MD registration will be a plus
Location:
Beijing
Regulatory Affairs Specilist
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CORE JOB TASK:
  • Prepare and submit registration application and dossier, follow up testing and evaluation procedure, obtain product license from CFDA independently.
  • Work closely to CFDA and testing center, establish and maintain good relationship.
  • Well coordinate with internal & external customers, have great communication skills – need to liaise with a lot of different parties both inside and outside the company (including oversea sponsor, medical department, testing center and evaluation center etc.).
  • Adapt to rapid changes in business environment, meet different requirements.
REQUIREMENTS:
  • Master or above degree of medical, chemistry, pharmaceutical, biological, or relatives.
  • Excellent inter-personal, communication and presentation skill. Fluency (oral and written) in both Chinese and English. Be patient and earnest on product registration projects.Good team player.
  • Independent handle project ability
  • With experience in handling imported drug registration will be a plus
Location:
Beijing
Statistical Programmer
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CORE JOB TASK:
  • Develops SAS Programs to implement statistical analysis to generate analysis datasets as specified in the statistical analysis plan;
  • Develop SAS Programs to implement statistical analysis to generate tables, listing and figures as specified in the statistical analysis plans.
  • Performs validation of and quality assurance aspects of all SAS Programming activities.
  • Maintain documentation as appropriate.
REQUIREMENTS:
  • Education: Bachelor’s degree and/or equivalent in computer science, statistics, Mathematics, or other scientific field (or equivalent theoretical/technical depth).
  • Experience in development of Programs though SAS, Matlab, R or other computer language.
  • Knowledge of relational database and SQL programming.
  • Fluent in written and spoken English.
Location:
Beijing, Shanghai, Nanjing, Chengdu
Senior Statistical Programmer
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CORE JOB TASK:
  • Represent statistical programming at internal and client meeting. Act as a Statistical Programming consultant to clients and internal customers in related disciplines.
  • Plan statistical programming activities, manage timeline and lead study programmers to deliver deliverables with quality within timeline.
  • Develops SAS Programs to implement statistical analysis to generate analysis datasets as specified in the statistical analysis plan;
  • Develop SAS Programs to implement statistical analysis to generate tables, listing and figures as specified in the statistical analysis plans.
  • Performs validation of and quality assurance aspects of all SAS Programming activities.
  • Maintain documentation as appropriate.
REQUIREMENTS:
  • 3+ years of experience with proven SAS skill within a clinical trial environment.
  • Knowledge in all aspects of clinical trials from initial study set-up to study completion.
  • Education: Bachelor’s degree and/or equivalent in computer science, statistics, Mathematics, or other scientific field (or equivalent theoretical/technical depth).
  • Experience in development of SAS code.
  • SAS (BASE, STAT, Macro, Graph).
  • Knowledge of relational database and SQL programming.
  • Fluent in written and spoken English.
Location:
Beijing, Shanghai, Nanjing, Chengdu
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